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Clots low with experimental stent, FDA finds

Patients treated with Abbott Laboratories Inc’s experimental drug-coated heart stent had low rates of blood clots and heart attacks up to two years later, medical reviewers said.
/ Source: Reuters

Patients treated with Abbott Laboratories Inc’s experimental drug-coated heart stent had low rates of blood clots, heart attacks and cardiac-related deaths up to two years later, U.S. medical device reviewers said in documents released on Tuesday.

Food and Drug Administration staff also said Abbott’s Xience device had “favorable” outcomes on a key measure of effectiveness when compared with Boston Scientific Corp’s Taxusstent.

The rate of heart-related deaths was comparable between Xience and Taxus after one year, the FDA staff said in a summary released ahead of an advisory panel review on Thursday.